How one company is unlocking access to train entire Decon teams to understand this key Decontamination regulation.
A Decontamination Unit is only as good as its QMS (or Quality Management System, for the uninitiated). ISO 13485 is the international Standard for the design, production, installation and servicing of medical devices, and is an instrumental document for anyone working in a Decontamination Unit. Regulatory expectations place a responsibility on everybody working within a Decontamination Unit to manage risk, maintain documented records and follow the processes set out in their Unit’s QMS. It isn’t just the responsibility of management, or one person tasked with maintaining the QMS.
That’s one reason why everyone in a Decontamination Unit should understand ISO 13485. The second reason is that a huge part of every QMS is the embedding of continuous improvement and the constant iteration of processes to reduce risk, improve safety and enhance efficiency. There is nobody better placed to suggest an improvement to a process than the person who carries out that process day in and day out. That’s why everybody working inside the processes set out in a QMS should feel confident in suggesting improvements and being part of implementing those changes. Engaging all staff in the QMS as a collaborative, team-driven activity is a sign of an outstanding Decontamination Unit.
Engaging all staff in the QMS as a collaborative, team-driven activity is a sign of an outstanding Decontamination Unit.
The challenge comes in spreading this awareness and fostering this engagement. Clause 5.3 talks about top management establishing a quality policy that is communicated and understood at all levels. Clause 5.5 talks about ensuring all staff understand how their work affects the QMS. Clause 6.2 talks about personnel being competent, properly trained and aware of how their activities contribute to quality and regulatory compliance. And Clause 8.5 talks about continuous improvement, which in part relies on employees reporting issues, participating in investigations and supporting corrective or preventive actions.
So, it seems obvious then that all staff within the scope of a QMS should be trained to understand ISO 13485 and their role in it. But all too often, it’s not as easy as that. Internal pressures, whether they are operational or budgetary, make it difficult to provide that level of training to all staff, and many departments find themselves offering training only to their Quality Manager (who is then tasked with cascading this learning internally) or a small group of internal auditors.
Regulatus are doing things differently. Their online course, “Understanding ISO 13485”, suddenly opens up a route to provide equal access to this crucial standard to everyone within a Decontamination Unit. Online learning can never replace classroom training in every aspect, but it brings its own advantages. First, learners can access the course in what is termed “fragmented time.” No need for a day out of the Unit, or for whole groups to be excused at once. Instead, learners can choose when and how they access the content, when time and operational pressures permit, and most importantly when they feel ready to engage and absorb the information at their own pace. Quality managers and internal auditors no longer need to become trainers and carry that responsibility – instead, they can monitor learner progress and engagement via a remote dashboard that gives them assurance and evidence of learning. Top management can achieve their quality objectives by demonstrating that every single member of their team has CPD certification in “Understanding ISO 13485.”
View a sample of “Understanding ISO 13485” below, and contact us for more information on how to unlock this CPD accredited learning for your entire team.
